Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study

Официальное название

Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network (STOP-VTE)

Обзор

This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate self-reported utilization of guideline concordant extended venous thromboembolism (VTE) prophylaxis (ePPx) following abdominopelvic cancer surgery within a sample of surgeons practicing within NCORP based on the Part 1 surgeon survey.

SECONDARY OBJECTIVES:

I. Evaluate site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) and surgeon factors (e.g., fellowship training, years in practice) associated with surgeon self-reported guideline concordant ePPx utilization (Part 1).

II. Conduct semi-structured interviews among a subset of surgeons and surgical APPs to assess: 1) Barriers/facilitators toward ePPx after cancer surgery and 2) Acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2).

III. Extract EHR data from select practices to assess the feasibility of query-based electronic health record (EHR) data extraction for identification of (i) patients undergoing cancer surgery, and (ii) prescription of guideline concordant ePPx among eligible patients (Part 3).

OUTLINE: This is an observational study.

PART 1: Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or Cancer Care Delivery Research (CCDR) lead complete site surveys on study.

PART 2: A subset of surgeons and APPs from part 1 complete a semi-structured interview on study.

PART 3: Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.

Вмешательства

• Другое Non-Interventional Study
  Non-interventional study
• Другое Non-Interventional Study
  Non-interventional study
• Другое Non-Interventional Study
  Non-interventional study

Первичные конечные точки

• Self-reported utilization of guideline concordant ePPx for surgeons (Part 1) [Срок оценки: After 1 year from start of Part 1]

Вторичные конечные точки (3)

• Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1) [Срок оценки: After 1 year from start of Part 1]
• Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2) [Срок оценки: After 6 months from start of Part 2]
• Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3) [Срок оценки: After 6 months from start of Part 3]

Критерии участия

Критерии включения

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)

SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:

\* Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP

Критерии исключения

• N/A

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 58 центров

• Mercy Hospital Fort Smith — Fort Smith
• Helen F Graham Cancer Center — Newark
• Medical Oncology Hematology Consultants PA — Newark
• Christiana Care Health System-Christiana Hospital — Newark
• Northside Hospital — Atlanta
• Augusta University Medical Center — Augusta
• Northside Hospital - Gwinnett — Lawrenceville
• Carle Cancer Center — Urbana
• … и ещё 50 центров

Пуэрто-Рико · 1 центр

• San Patricio Medflix — Guaynabo

Идентификаторы

NCT: NCT07215624 · IRB00138219 · NCI-2025-06376 · WF-2502CD · WF-2502CD · WF-2502CD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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